EUCTR2013-003817-16-ESActive, not recruitingNot Applicable
A phase III, randomized, controlled, single-blind,multicentre, parallel arm trial to assess theefficacy and safety of Pergoveris® (follitropin alfaand lutropin alfa) and GONAL-f® (follitropinalfa) for multifollicular development as part of anassisted reproductive technology treatment cyclein poor ovarian responders, as defined by theEuropean Society of Human Reproduction andEmbryology criteria - Pergoveris? in ART
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Merck KGaA
- Enrollment
- 946
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •The current trial will enroll poor ovarian responders according to specific criteria that are aligned with the POR criteria defined by ESHRE.
- •At least 2 of the following 3 features must be present:
- •- Advanced maternal age (? 40 years)
- •- A previous POR (? 3 oocytes with a conventional stimulation protocol)
- •- An abnormal ovarian reserve test (ORT) (ie, anti-mullerian hormone [AMH] < 0.5 - 1.1 ng mL)
- •Additional inclusion criteria are:
- •1. Female subjects, 18 to < 41 years of age (according to date of birth at time of informed consent) who are eligible for ovarian stimulation and ART treatment, including ICSI
- •2. Absence of anatomical abnormalities of the reproductive tract that would interfere with implantation or pregnancy
- •3. Absence of any medical condition in which pregnancy is contraindicated
- •4. Body mass index 18 to 30 kg/m2, inclusive
- •5. Motile, ejaculatory sperm must be available (donated and/or cryopreserved sperm is allowed). Intracytoplasmic sperm injection will be allowed during this trial.
- •6. Minimum of 1 month without treatment with either clomiphene citrate or gonadotrophins prior to screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 946
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. Two episodes of POR after maximal stimulation
- •2. History or presence of tumors of the hypothalamus or pituitary gland
- •3. History or presence of ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst > 25 mm on the day of randomization
- •4. Presence of endometriosis grade III ? IV, confirmed or suspected
- •5. Presence of uni- or bilateral hydrosalpinx
- •6. Abnormal gynecological bleeding of undetermined origin
- •7. Contraindication to being pregnant and/or carrying a pregnancy to term
- •8. History or presence of ovarian, uterine or mammary cancer
- •9. Use of testicular or epididymal sperm
Investigators
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